Balloon suction catheter

Abstract

The invention discloses a balloon suction catheter, which comprises a hollow guide catheter and a balloon suction catheter, the suction inner tube is arranged in a hollow mode and coaxially fixed to the inner side of the guide catheter, the near end of the suction inner tube extends out of the near end of the guide catheter, the guide catheter and the suction inner tube are arranged in a spaced mode to form an air flow channel, and the near end of the air flow channel is closed; the balloon wraps the outer side of the guide catheter and is arranged close to the near end of the guide catheter, the balloon and the guide catheter enclose to form an expansion space, the guide catheter is provided with a vent hole, and the vent hole is communicated with the airflow channel and the expansion space. According to the balloon suction catheter, thrombus suction and the balloon are combined, the operation time can be shortened in the operation process, the phenomenon that due to the fact that balloon guide catheters and thrombus suction catheters produced by different farmers are different in specification, the balloon guide catheters and the thrombus suction catheters are not matched is avoided, the operation time is shortened, and the operation cost is reduced.

Description

Technical Field

[0001] The present application belongs to the technical field of thrombus removal, and specifically relates to a balloon aspiration catheter. Background Art

[0002] In recent years, percutaneous mechanical thrombectomy, also known as mechanical embolectomy, has been widely used in clinical practice. This technology is based on the principles of mechanics or fluid mechanics, and mechanically crushes and aspirates emboli through a suction catheter to achieve the purpose of recanalization of blood vessels. When PMT or thrombus aspiration is performed in clinical practice, a balloon guide catheter and a thrombus aspiration catheter are used together. When the balloon guide catheter reaches the carotid artery, the thrombus aspiration catheter is inserted into the thrombus aspiration catheter for thrombus aspiration. The balloon guide provides support for the thrombus aspiration catheter on the one hand, and fills the balloon through the overflow port of the balloon guide catheter on the other hand, which plays a blocking role and prevents the embolus from escaping.

[0003] The medical device currently used for thrombus aspiration requires the use of a balloon guide catheter and a thrombus aspiration catheter. The balloon guide catheter provides good support for the thrombus aspiration catheter and blocks the blood vessels to prevent thrombus escape, while the thrombus aspiration catheter performs thrombus aspiration. However, the use of two medical devices greatly prolongs the operation time, and the phenomenon of device mismatch is prone to occur during the operation, which increases the risk of the operation. Summary of the invention

[0004] The present application provides a balloon aspiration catheter to improve the safety of thrombus aspiration surgery.

[0005] To solve the above technical problems, a technical solution adopted in the present application is: a balloon aspiration catheter, comprising: a guide catheter, which is hollow; an inner suction tube, which is hollow and coaxially fixed to the inner side of the guide catheter, the proximal end of the inner suction tube extends to the outside of the proximal end of the guide catheter, the guide catheter and the inner suction tube are spaced apart to form an air flow channel, and the air flow channel is closed at the proximal end; a balloon, which is wrapped around the outer side of the guide catheter and arranged close to the proximal end of the guide catheter, the balloon and the guide catheter are surrounded to form an expansion space, the guide catheter is provided with a vent hole, and the vent hole connects the air flow channel and the expansion space.

[0006] According to one embodiment of the present application, the guide catheter is symmetrically provided with at least two groups of ventilation holes in the circumferential direction, each group of ventilation holes is provided with at least two ventilation holes at circumferential intervals, the balloon is wrapped around the periphery of the ventilation holes, and both ends of the balloon are connected to the outer wall of the guide catheter.

[0007] According to one embodiment of the present application, developing parts are respectively provided at both ends of the balloon.

[0008] According to one embodiment of the present application, the suction inner tube includes an inner tube, a middle tube and an outer tube which are stacked from the inside to the outside.

[0009] According to one embodiment of the present application, the inner tube is a polytetrafluoroethylene etched tube.

[0010] According to one embodiment of the present application, the intermediate tube includes a first intermediate tube segment and a second intermediate tube segment connected to each other, the first intermediate tube segment is closer to the distal end than the second intermediate tube segment, the first intermediate tube segment is a metal coil structure, and the second intermediate tube segment is a metal braided structure.

[0011] According to one embodiment of the present application, the first intermediate pipe section is formed by spirally winding a first metal wire to form a metal coil; the length of the first intermediate pipe section is 10cm-130cm, the first metal wire is made of stainless steel material or nickel-titanium material, and / or the first metal wire is a flat wire or a round wire, and / or the axial spacing between two adjacent turns of the metal coil is 0.01mm-0.3mm.

[0012] According to one embodiment of the present application, the second intermediate pipe section is made of 16 or 24 strands of second metal wires, and is woven in a diamond-shaped weaving manner that is interwoven up and down; the second metal wire is made of stainless steel material, and / or the second metal wire is made of flat wire, and / or the weaving density of the second metal wire is set to 70-100ppi.

[0013] According to one embodiment of the present application, the outer tube includes a first outer tube segment, a second outer tube segment and a third outer tube segment connected in sequence from the distal end to the proximal end. The first outer tube segment is a thermoplastic polyurethane tube, the second outer tube segment is a polyether block polyamide tube, and the third outer tube segment is a nylon tube.

[0014] According to one embodiment of the present application, the guide catheter includes multiple polyether block polyamide tube segments connected in sequence from the distal end to the proximal end, and the hardness of the multiple polyether block polyamide tube segments gradually increases from the distal end to the proximal end.

[0015] The beneficial effects of the present application are as follows: the balloon aspiration catheter in the present application adopts a coaxial double-lumen structural design, and cleverly combines the existing thrombus aspiration catheter and the balloon guide catheter, so that the aspiration of thrombus can be achieved to achieve the effect of vascular patency. Specifically, by setting a coaxially fixed guide catheter and a suction inner tube. The guide catheter provides effective support for the suction inner tube, and the proximal end of the suction inner tube extends to the outside of the proximal end of the guide catheter, and thrombus aspiration can be performed. The airflow channel between the guide catheter and the suction inner tube can provide fluid to the balloon, so that the balloon is filled and the blood vessel is blocked to prevent the thrombus from escaping. The balloon aspiration catheter of the present application combines the advantages of the existing thrombus aspiration catheter and the balloon guide catheter, and designs a balloon aspiration catheter that combines thrombus aspiration and balloon, which can reduce the operation time during surgery, and also avoid the mismatch caused by the difference in specifications of balloon guide catheters and thrombus aspiration catheters produced by different manufacturers, and reduces the time and cost of surgery, and improves safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work, among which:

[0017] Figure 1 It is a front structural schematic diagram of a balloon aspiration catheter according to an embodiment of the present application;

[0018] Figure 2 It is a schematic cross-sectional structure diagram of a guide catheter of a balloon aspiration catheter according to an embodiment of the present application;

[0019] Figure 3 is a schematic cross-sectional structure diagram of a guide catheter of a balloon aspiration catheter according to another embodiment of the present application;

[0020] Figure 4 It is a schematic diagram of the cross-sectional structure of the suction inner tube according to an embodiment of the present application.

[0021] In the figure: 100, balloon aspiration catheter; 110, guide catheter; 120, aspiration inner tube; 121, inner tube; 122, intermediate tube; 1221, first intermediate tube segment; 1222, second intermediate tube segment; 123, outer tube; 1231, first outer tube segment; 1232, second outer tube segment; 1233, third outer tube segment; 130, balloon; 140, vent; 150, developing part; 160, catheter seat; 161, first branch tube; 162, second branch tube; 170, diffusion stress tube. DETAILED DESCRIPTION

[0022] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. It is to be understood that the specific embodiments described herein are only used to explain the present application, rather than to limit the present application. It should also be noted that, for ease of description, only some structures related to the present application are shown in the accompanying drawings, rather than all structures. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0023] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0024] For the convenience of description below, the end of each component in the balloon aspiration catheter 100 away from the operator when in use is referred to as the "distal end", and the end of each component in the balloon aspiration catheter 100 close to the operator when in use is referred to as the "proximal end".

[0025] See also Figure 1 , Figure 1 It is a front structural schematic diagram of a balloon aspiration catheter according to an embodiment of the present application.

[0026] An embodiment of the present application provides a balloon aspiration catheter 100. The balloon aspiration catheter 100 includes a guide catheter 110, an inner suction tube 120 and a balloon 130. The guide catheter 110 is hollow. The inner suction tube 120 is hollow and coaxially fixed to the inner side of the guide catheter 110. The proximal end of the inner suction tube 120 extends to the proximal outside of the guide catheter 110. The guide catheter 110 and the inner suction tube 120 are spaced apart to form an air flow channel (not shown in the figure), and the air flow channel is closed at the proximal end. The balloon 130 is wrapped around the outside of the guide catheter 110 and is arranged near the proximal end of the guide catheter 110. An expansion space is formed between the balloon 130 and the guide catheter 110. The guide catheter 110 is provided with a vent 140, which connects the air flow channel and the expansion space.

[0027] The balloon aspiration catheter 100 in the present application adopts a coaxial double-lumen structural design, which cleverly combines the existing thrombus aspiration catheter and the balloon guide catheter, and can achieve the effect of aspiration of thrombus to achieve patency of blood vessels. Specifically, by setting a coaxially fixed guide catheter 110 and a suction inner tube 120. The guide catheter 110 provides effective support for the suction inner tube 120, and the proximal end of the suction inner tube 120 extends to the outside of the proximal end of the guide catheter 110, and thrombus aspiration can be performed. The airflow channel between the guide catheter 110 and the suction inner tube 120 can provide fluid to the balloon 130, so that the balloon 130 blocks the blood vessel after filling to prevent the escape of the thrombus.

[0028] The balloon aspiration catheter 100 of the present application combines the advantages of existing thrombus aspiration catheters and balloon guide catheters, and designs a balloon aspiration catheter 100 that combines thrombus aspiration and a balloon. It can reduce the operation time during surgery, avoid the mismatch caused by the difference in specifications of balloon guide catheters and thrombus aspiration catheters produced by different manufacturers, reduce the time and cost of surgery, and improve safety.

[0029] Please continue reading Figure 2 and Figure 3 , Figure 2 It is a schematic cross-sectional structure diagram of a guide catheter of a balloon aspiration catheter according to an embodiment of the present application; Figure 3 It is a schematic cross-sectional structure diagram of a guide catheter of a balloon aspiration catheter according to another embodiment of the present application.

[0030] In some embodiments, the guide catheter 110 is symmetrically provided with at least two groups of vent holes 140 in the circumferential direction, and each group of vent holes 140 is circumferentially spaced with at least two vent holes 140. The balloon 130 is wrapped around the circumference of the vent holes 140, and both ends of the balloon 130 are connected to the outer wall of the guide catheter 110.

[0031] By setting the balloon 130 on the guide catheter 110, the connection between the balloon 130 and the guide catheter 110 is stable, and the balloon 130 can be stably filled and contracted through the airflow channel, which has a better blocking effect on the thrombus. By evenly setting multiple vents 140 on the guide catheter 110, the fluid exchange efficiency between the airflow channel and the balloon 130 is higher, further improving the safety of the operation.

[0032] Specifically, both ends of the balloon 130 are respectively glued to the outer wall of the guide catheter 110 by glue.

[0033] Specifically, the guide catheter 110 is symmetrically provided with two groups of vent holes 140 in the circumferential direction, and each group of vent holes 140 includes two vent holes 140 spaced apart along the circumferential direction of the guide catheter 110. The spacing between the two vent holes 140 is 2 mm to 6 mm, such as 2 mm, 3 mm, 5 mm or 6 mm, etc. The minimum distance between the connection position between the end of the balloon 130 and the guide catheter 110 and the vent hole 140 is 2 mm.

[0034] In order to indicate the distal end of the guide catheter 110 and the position of the balloon 130, in some embodiments, both ends of the balloon 130 are provided with developing parts 150. The developing parts 150 can be visualized under radiation, so that the balloon 130 is located at an accurate position in the blood vessel.

[0035] Specifically, the developing member 150 may be a developing ring, which is located at the position where the guide catheter 110 connects two ends of the balloon 130 .

[0036] When the guide catheter 110 and the suction inner tube 120 are assembled, the suction inner tube 120 and the guide catheter 110 can be inserted into the guide catheter 110, and the distal end of the suction inner tube 120 is exposed 4 cm to 15 cm at the distal end of the guide catheter 110 according to needs, such as 4 cm, 8 cm, 12 cm or 15 cm. The guide catheter 110 and the suction inner tube 120 are welded and fixed using a balloon welding machine.

[0037] See also Figure 1 In some embodiments, the balloon aspiration catheter 100 further includes a catheter seat 160. The catheter seat 160 is fixed to the proximal end of the guide catheter 110 and is sleeved on the outside of the guide catheter 110. The proximal end of the catheter seat 160 is provided with a first branch tube 161 and a second branch tube 162, and an angle is formed between the first branch tube 161 and the second branch tube 162. The first branch tube 161 is connected to the internal cavity of the aspiration inner tube 120, and the second branch tube 162 is connected to the airflow channel between the aspiration catheter and the guide catheter 110.

[0038] Further, the balloon aspiration catheter 100 also includes a diffusion stress tube 170. The diffusion stress tube 170 is connected to the distal end of the catheter seat 160. The proximal end of the guide catheter 110 is fixed to the inner wall of the diffusion stress tube 170, and the proximal end of the suction inner tube 120 is fixed to the inner wall of the catheter seat 160. The diffusion stress tube 170 improves the torque resistance of the suction inner tube 120 and the guide catheter 110 to prevent the suction inner tube 120 and the guide catheter 110 from being broken. The proximal end of the suction inner tube 120 is fixed to the catheter seat 160 using UV glue, and the guide catheter 110 and the diffusion stress tube 170 are fixed using UV glue.

[0039] See also Figure 4 , Figure 4It is a schematic diagram of the cross-sectional structure of the suction inner tube according to an embodiment of the present application.

[0040] In some embodiments, in order to improve the performance of the suction inner tube 120, the suction inner tube 120 can be set as a multi-layer composite tube. The suction inner tube 120 includes an inner tube 121, an intermediate tube 122, and an outer tube 123 stacked from the inside to the outside. Compared with a tube structure with a single structure, the inner tube 121, the intermediate tube 122, and the outer tube 123 of the suction inner tube 120 can select a suitable structure according to the needs of the suction inner tube 120 to achieve better passability, support, and thrombus suction function.

[0041] The inner tube 121 is made of polytetrafluoroethylene (PTFE) etched tube.

[0042] The intermediate tube 122 includes a first intermediate tube section 1221 and a second intermediate tube section 1222 connected to each other. The first intermediate tube section 1221 is close to the distal end relative to the second intermediate tube section 1222, and the first intermediate tube section 1221 is a metal coil structure. The second intermediate tube section 1222 is a metal braided structure. The first intermediate tube section 1221 with a metal coil structure has better deformation ability, can adapt to the direction of the blood vessel, and has better passing performance. The second intermediate tube section 1222 with a metal braided structure has better supporting performance. The intermediate tube 122 is formed by connecting the first intermediate tube section 1221 and the second intermediate tube section 1222, and has better passing performance and supporting performance.

[0043] Specifically, the first intermediate pipe section 1221 is formed by spirally winding a first metal wire to form a metal coil. The first metal wire is made of stainless steel, such as stainless steel 304; of course, the first metal wire can also be made of nickel-titanium material. The first metal wire is a flat wire or a round wire. The axial spacing between the first metal wires of two adjacent turns of the metal coil is 0.01mm-0.3mm, such as 0.01mm, 0.15mm or 3mm. The length of the first intermediate pipe section 1221 is 10cm-130cm, such as 10cm, 30cm, 50cm, 80cm, 100cm or 130cm. The parameters of the first intermediate pipe section 1221 can be adjusted according to actual needs. Within the above range, the first intermediate pipe section 1221 has good deformation ability and passing performance.

[0044] Specifically, the second intermediate pipe section 1222 is made of 16 or 24 strands of the second metal wire, and is woven in a diamond-shaped weaving manner that is interwoven up and down. The second metal wire is made of stainless steel. The second metal wire is a flat wire. The weaving density of the second metal wire is set to 70-100ppi, such as 70ppi, 86ppi or 100ppi. The parameters of the second intermediate pipe section 1222 can be adjusted according to actual needs. Within the above range, the second intermediate pipe section 1222 has good supporting performance.

[0045] The distal end of the guide catheter 110 is designed with a nickel-titanium wire coil to provide excellent support and resilience, and the proximal braided design can provide support and ensure the safety of the operation.

[0046] In some embodiments, the outer tube 123 is made of multiple materials. The outer tube 123 includes a first outer tube segment 1231, a second outer tube segment 1232, and a third outer tube segment 1233 connected in sequence from the distal end to the proximal end. The hardness of the first outer tube segment 1231, the second outer tube segment 1232, and the third outer tube segment 1233 gradually increases, and the transition is smooth.

[0047] The first outer tube section 1231 is made of a thermoplastic polyurethane (TPU) tube with low hardness and good biocompatibility. Specifically, the first outer tube section 1231 is made by cutting TPU 45A, TPU 60A, and TPU 80A into different lengths and splicing and coating them in sequence. The design length of the first outer tube section 1231 is 10 cm-50 cm, such as 10 cm, 25 cm, or 50 cm.

[0048] The second outer tube section 1232 is a polyether block polyamide (PEBAX) tube. Specifically, the second outer tube section 1232 is made of a variety of PEBAX, which is made of PEBAX2533, PEBAX3533, PEBAX4033, PEBAX5533, PEBAX633, and PEBAX7233 materials of different hardness, which are sequentially spliced ​​and coated to provide an excellent smooth transition of the thrombus suction inner tube 120.

[0049] The third outer tube section 1233 is a nylon tube. Specifically, the third outer tube section 1233 is made of nylon film.

[0050] See also Figure 2 In some embodiments, the guide catheter 110 is a single-layer structure. The guide catheter 110 includes multiple segments of polyether block polyamide (PEBAX) tube segments connected in sequence from the distal end to the proximal end, and the hardness of the multiple segments of polyether block polyamide tube segments gradually increases from the distal end to the proximal end. Specifically, from the distal end to the proximal end, PEBAX 2533, PEBAX 3533, PEBAX 4333, PEBAX 5533, PEBAX 6333, and PEBAX 7233 are assembled and welded in sequence to form a coaxial single guide catheter 110, and the length is designed to be 110-136 cm.

[0051] See also Figure 3In some embodiments, the guide catheter 110 is a double-layer structure. The inner layer of the guide catheter 110 is a polytetrafluoroethylene (PTFE) etched tube. The outer layer of the guide catheter 110 includes multiple segments of polyether block polyamide (PEBAX) tube segments connected in sequence from the distal end to the proximal end, and the hardness of the multiple segments of polyether block polyamide tube segments gradually increases from the distal end to the proximal end. Specifically, from the distal end to the proximal end, PEBAX 2533, PEBAX 3533, PEBAX 4333, PEBAX 5533, PEBAX 6333, and PEBAX 7233 are assembled and welded in sequence to form a coaxial single pipeline, and the length is designed to be 110-136 cm.

[0052] The balloon aspiration catheter 100 of the present application is made of a variety of materials, which ensures the flexibility of the distal end and the support of the proximal end, and can enable the balloon aspiration catheter 100 to reach the target position better.

[0053] It should be noted that the terms "horizontal", "vertical" and the like do not mean that the components are absolutely horizontal or vertical, but can be slightly tilted; the terms "parallel", "vertical" and the like do not mean that the components are absolutely parallel or vertical, but can form a certain angle deviation. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted. In addition, the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate the orientation or position relationship based on the orientation or position relationship shown in the drawings, or the orientation or position relationship in which the product of the present application is usually placed when used, which is only for the convenience of describing the embodiments of the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present application.

[0054] The above description is only an implementation method of the present application, and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A balloon aspiration catheter, characterized in that: include: The guide catheter is hollow; The suction inner tube is hollow and coaxially fixed to the inner side of the guide catheter. The proximal end of the suction inner tube extends to the outside of the proximal end of the guide catheter. The guide catheter and the suction inner tube are spaced apart to form an airflow channel. The airflow channel is closed at the proximal end. The balloon is wrapped around the outside of the guide catheter and is arranged near the proximal end of the guide catheter. An expansion space is formed between the balloon and the guide catheter. The guide catheter is provided with a vent hole, which connects the airflow channel and the expansion space.

2. The balloon aspiration catheter according to claim 1, characterized in that: The guide catheter is symmetrically provided with at least two groups of ventilation holes in the circumferential direction, each group of ventilation holes is provided with at least two ventilation holes at intervals in the circumferential direction, the balloon is wrapped around the periphery of the ventilation holes, and both ends of the balloon are connected to the outer wall of the guide catheter.

3. The balloon aspiration catheter according to claim 2, characterized in that: The two ends of the balloon are respectively provided with developing parts.

4. The balloon aspiration catheter according to claim 1, characterized in that: The suction inner tube comprises an inner tube, a middle tube and an outer tube which are stacked from the inside to the outside.

5. The balloon aspiration catheter according to claim 4, characterized in that: The inner tube is a polytetrafluoroethylene etched tube.

6. The balloon aspiration catheter according to claim 4, characterized in that: The intermediate tube comprises a first intermediate tube section and a second intermediate tube section connected to each other. The first intermediate tube section is closer to the distal end than the second intermediate tube section. The first intermediate tube section is a metal coil structure, and the second intermediate tube section is a metal braided structure.

7. The balloon aspiration catheter according to claim 6, characterized in that: The first intermediate pipe section is formed by spirally winding a first metal wire to form a metal coil; the length of the first intermediate pipe section is 10cm-130cm, the first metal wire is made of stainless steel or nickel-titanium material, and / or the first metal wire is a flat wire or a round wire, and / or the axial spacing between two adjacent turns of the metal coil is 0.01mm-0.3mm.

8. The balloon aspiration catheter according to claim 6, characterized in that: The second intermediate tube section is made of 16 or 24 strands of second metal wires, woven in a diamond-shaped weaving pattern that interweaves up and down; the second metal wire is made of stainless steel, and / or the second metal wire is flat wire, and / or the weaving density of the second metal wire is set to 70-100ppi.

9. The balloon aspiration catheter according to claim 4, characterized in that: The outer tube includes a first outer tube segment, a second outer tube segment and a third outer tube segment connected in sequence from the distal end to the proximal end. The first outer tube segment is a thermoplastic polyurethane tube, the second outer tube segment is a polyether block polyamide tube, and the third outer tube segment is a nylon tube.

10. The balloon aspiration catheter according to claim 1, characterized in that: The guide catheter comprises a plurality of polyether block polyamide tube segments connected in sequence from the distal end to the proximal end, and the hardness of the plurality of polyether block polyamide tube segments gradually increases from the distal end to the proximal end.

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